St. Jude Medical Takes Home Innovation Award for Leadless Pacemaker

The Nanostim leadless pacemaker from St. Jude Medical Inc. took home an international award this week. One of the company’s latest technologies received the 2014 Innovation Award at Cardiostim 2014, the 19th World Congress in Cardiac Electrophysiology and Cardiac Techniques held in Nice, France. The award was chosen by a congress committee of electrophysiologists.

“St. Jude Medical is honored that our Nanostim pacemaker received this significant recognition from the EP (electrophysiology) community,” said Eric S. Fain, M.D., group president of St. Jude Medical. “With more than 55 years of history in pacing innovation, we are proud that this revolutionary technology is transforming the treatment of cardiac arrhythmias and setting a new standard of care for future pacing technologies. We believe that the health benefits associated with this leadless technology will enable physicians who use this device to improve the lives of patients worldwide.”

More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.

Unlike conventional pacemakers that require a more invasive surgery, the Nanostim leadless pacemaker is designed to be implanted directly into the heart via a non-surgical procedure. The device, which earned European CE mark approval in 2013, is designed to be placed without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein (in the leg) with a tiny delivery system, the device is designed to be fully retrievable so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.

The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and is the least invasive pacing technology on the market today, company officials claim. The small size of the device and lack of a surgical pocket, coupled with the exclusion of a lead, improves patient comfort and can reduce traditional pacemaker complications, including device pocket-related infection and lead failure, St. Jude Medical officials noted. The device battery is expected to have an average lifespan of more than nine years at 100 percent pacing, or more than 13 years at 50 percent pacing.

Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient’s specific physiological requirements.

From 2010 to 2012, St. Jude Medical experienced problems with a few of its lines of traditional pacemaker leads (the tine wires that connect the heart to the implantable device). In late 2010, the company shelved Riata defibrillator leads after an Irish study showed wires came through the lead’s outer coating. The U.S. Food and Drug Administration issued a recall of the Riata leads in December 2011.

Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.